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NCT Number: NCT04319588

Parasternal Block for Cardiac Surgery

This study examine the effect of Parasternal Intercostal Nerve Blocks with local anesthetic on pain control in patients undergoing non-emergent cardiac surgery in a prospective controlled trial. Half of participants will receive General Anesthesia combined to parasternal block while the other half receive only General Anesthesia.

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Key information

Conditions

Cardiac Disease Acute Pain Agnosia Analgesia Cardiovascular Diseases Heart Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Campus Biomedico University

Rome, Roma, 00128, Italy

About this study

60 patients undergoing elective cardiac surgery will be enrolled and divided into two groups:

  • Interventional (parasternal group)
  • Case control group The "parasternal group" of patients will receive the pre-operative parasternal block (20 ml of 0.5% Ropivacaine per side) in association with infiltration with local anesthetic of access to thoracic drainage (drainage infiltration with 20 ml of 0.25% Ropivacaine) at the end of the intervention combined to General Anesthesia.

The "case control group" will only receive drainage infiltration with local anesthetic and standard intraoperative management with opioids.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing elective cardiac surgery
  • Age over 18 years
  • ASA I-IV
  • Approval by the patient of informed consent

Exclusion criteria

  • Allergy to local anesthetics
  • Puncture site infection
  • Lack of signing of informed consent
  • Weight <30 Kg
  • Age <18 years
  • Emergency interventions
  • ASA > IV
  • Sternal dehiscences
  • Dementia (for difficulties in managing weaning from mechanical ventilation and pain)

Treatment and study plan

Parasternal Block+ Infiltration with local anesthetic of access to thoracic drainage

Procedure

After induction of general anesthesia we will perform an ultrasound-guided Parasternal Block in association with infiltration with local anesthetic of access to thoracic drainage at the end of the intervention.

Infiltration with local anesthetic of access to thoracic drainage

Procedure

Infiltration with local anesthetic of access to thoracic drainage at the end of the intervention.

Primary outcomes

  1. Maximum Pain Score

    Time frame: 24 hours

    Postoperative pain assessment using the NRS scale (score from 0 to 10)

Secondary outcomes

  1. Respiratory performance at the TRI-FLOW

    Time frame: 24 hours

    Respiratory performance is assessed by the number of balls raised during inspiration with the TRI-FLOW

  2. Intraoperative opioid administration

    Time frame: 4 hours

    Quantitative evaluation of opioids needed in the intraoperative period

  3. Total opioids consumption

    Time frame: 24 hours

    Number of opioid deliveries (bolus morphine) in the postoperative period

  4. Time to first opioid

    Time frame: 48 hours

    The time in minutes between awakening and the first opioid administration

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study title

Parasternal Block for Postoperative Analgesia in Cardiac Surgery: a Pilot Controlled Trial

Acronym: Parasternal

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 24, 2020
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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